PHILADELPHIA, PENNSYLVANIA, UNITED STATES, May 8, 2017 /EINPresswire.com/ — Premia Spine, Ltd. announced today that it has secured FDA approval for its pivotal study of the new TOPS™ System.

“We are excited about the opportunity to provide U.S. patients with access to the only posterior arthroplasty device for degenerative grade I spondylolisthesis and spinal stenosis, with thickening of the ligament or scarring of the facet capsule,” said Ron Sacher, CEO of Premia Spine.

The new TOPS device, with a 30% smaller footprint and a simpler surgical technique from the original device, has been in commercial use in Europe for over 5 years.

The IDE study will take place in 30 institutions and enroll 330 subjects. Patients will be randomized to either the TOPS™ System or lumbar fusion (i.e., an interbody cage plus screws and rods), with a 67% likelihood of receiving the TOPS device.

Clinical sites will be measuring ODI, VAS, neurologic function, device integrity, reoperation rates and other quantitative outcomes for the study device and the fusion control. “Our goal is to establish the superiority of the TOPS™ System versus traditional lumbar spinal fusion,” explains Mr. Sacher.

About Premia Spine. Premia Spine licensed the TOPS System technology in 2011 from Impliant, Ltd. Over $100 million has been invested to design, develop, and commercialize the TOPS System, with over 12 years of clinical use and 1,000 patients.

Drue has been helping orthopedic companies overcome challenges since starting the firm in 2000. Direct orthopedic industry experience informs Drue’s perspective on who is best suited to take companies to the next level. A father of four, Drue strives to live a life of integrity and commitment to excellence. Prior to starting TDG, Drue was at Zimmer for 10 years as a Multiple President's Club Achieving Sales Representative before being recruited by Stryker as Branch Manager of the Arizona Branch where he built an award winning team in Reconstruction, Trauma & Spine.